Associate Director, Biostatistics
Brisbane, CA, USA | Myovant Sciences Ltd.
Industry:Pharmaceutical / Biotech
Job Description:99 people have viewed this job
The Associate Director, Biostatistics provides direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. The Associate Director will be responsible for implementing consistent statistical conduct for the department and liaising with clinical research personnel in order to identify and meet their needs for statistical support. The Associate Director will also interact with the head of statistical programming and data management to synchronize prioritization of projects and, in some cases, represent Biostatistics in meetings with executive committee, commercial, regulatory agencies, and external development partners in the absence of the Head of Biostatistics.
Essential Duties and Responsibilities
Provides statistical expertise to study designs and clinical development strategy as a Subject Matter Expert and point of reference in Biostatistics to ensure scientific integrity of the statistical methodology applied to clinical trials.
Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
Provides input to development programs including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques.
Presents and discusses statistical considerations as the representative of the Biostatistics function at Protocol Review Meetings.
Prepares statistical analysis plans for integrated summary of safety (ISS) and integrated summary of efficacy (ISE) and statistical summary reports as appropriate.
Writes and/or reviews regulatory documents (e.g., ISS, ISE, regulatory Briefing books)
Contributes to the planning and preparation for discussions on statistical methodology and/or analyses and their use/interpretation at Health Authority Meetings.
Collaborates with other functional areas within the company (Clinical Data Management, Clinical Research, Global Drug Safety, Regulatory and Project Management).
Ensures that study/project-related biostatistics and programming work is carried out in a timely and compliant manner.
Researches and applies new statistical procedures as needed.
Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program (such as women’s health).
Other duties as assigned.
Core Competencies, Knowledge, and Skill Requirements
PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials. Women’s health or Oncology therapeutic area expertise is a plus.
Requires proficiency in SAS and an understanding of clinical data processing.
Knowledge of CDISC requirements for SDTM and ADaM.
Knowledge of FDA and ICH regulations/requirements as they pertain to the analysis, presentation/reporting, and monitoring of data.
Understands roles of Biostatistics, Statistical Programming and Data Management and provides adequate statistical expertise within a cross-functional team in clinical development.
Knowledge of other statistical and computational software packages (R, EaST, nQuery) is required.
Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions is a plus.
Excellent verbal and written communication skills.
Ability to effectively collaborate in a dynamic environment.
Experience with analysis and reporting of phase 3 study data, as well as integrated summary of efficacy and safety (ISE and ISS).
Experience with group-sequential designs and/or support of independent data monitoring committee for registration trials.
Experience with statistical methodology and analysis for clinical trials in endocrinology or oncology.
Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions desired.
Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used.
Ph.D. or M.S. in Biostatistics or Statistics, or equivalent related work experience.
Ph.D. and 6+ years of experience in Biostatistics; M.S. and 8+ years of experience in Biostatistics with extensive experience within the Pharmaceutical and/or Biotechnology industries.
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